BOSTON – The maker of Zohydro, a controversial new prescription painkiller, has filed a lawsuit in federal court seeking to block Massachusetts' ban on local doctors prescribing and dispensing the drug.

Zogenix filed suit in U.S. District Court in Massachusetts on Monday requesting that the court temporarily stop Massachusetts Governor Deval Patrick's executive order. A hearing is scheduled for Tuesday afternoon, according to court records.

The San Diego-based company argues in its lawsuit that Governor Patrick's order is at odds with the U.S. Food and Drug Administration, which approved use of Zohydro for severe pain in October.

Law enforcement and public health officials fear the powerful painkiller could worsen the nation's deadly scourge of heroin and prescription drug abuse.

In March, Governor Patrick declared a public health emergency in response to the state's growing epidemic of heroin and opioid addiction. As part of that announcement, the governor gave the state public health commissioner certain emergency powers, including banning Zohydro “until determined that adequate measures are in place to safeguard against the potential for diversion, overdose, and misuse.”

“Zohydro is a dangerously addictive pharmaceutical painkiller approved by the FDA recently, over the objection of their scientific advisory council and is not available in an abuse-deterrent form,” Patrick said during the press conference on March 27. “Until it is available in such a form or better until the secretary of HHS at the federal level or the Congress has acted on the request to overturn the FDA, Zohydro will not be available in Massachusetts.”

The ban is an “impermissible” effort by Massachusetts to set its own drug policy, Zogenix says in its suit. “It impedes the FDA's Congressional mandate to approve a range of safe treatments to promote the public health.”

The company said the lawsuit comes after a written request to meet with Gov. Patrick went unanswered. The governor's office referred questions to the state Department of Public Health, which said late Monday that it is reviewing the complaint.

Amy Larkin, a spokeswoman for Zogenix, said in an email there has been a “significant amount of misinformation in the media about Zohydro ER.”

“For patients in severe chronic pain who need hydrocodone, but are at risk for potentially fatal acetaminophen induced acute liver damage, Zohydro ER may be the only option for these patients to manage their pain,” Larkin wrote.

Larkin said Zohydro is not 10 times more powerful than Vicodin, and it is not the most powerful opiate in its class. There are other marketed opioids that are more potent than hydrocodone, such as oxymorphone, methadone, hydromorphone and fentanyl, she said.

“A state doesn't often overrule the FDA. But the states are well within their rights to block or approve drugs,” Dr. Kenneth Kaitin, a professor at the Tufts University School of Medicine and director of the Tufts Center for the Study of Drug Development, told the Cape Cod Times.

Heather Gray, the legislative attorney for the National Alliance for Model State Drug Laws told the Times that most states do not allow governors to ban drugs approved by the FDA because it would be a violation of the separation of powers doctrine.

“A lot of states do allow the state board of pharmacy, board of health, or similar agency to schedule/ban substances on a temporary, emergency basis, and that appears to be the case here,” she noted.

Vermont has also placed restrictions on the drug, albeit not an outright ban. “Many people wanted us to do what your governor did,” said Dr. Harry Chen, Vermont's commissioner of health, to the Times. “This is what we should have done with OxyContin,” he added.

Material from the Cape Cod Times and State House News Service was used in this report.